DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Brugada Syndrome, Sudden Cardiac Death Due to Cardiac Arrhythmia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DNA Methylation in Brugada Syndrome and Risk of Sudden Cardiac Death (ANDROMEDA)
Overview
The goal of this observational study is to evaluate if there are differences in DNA methylation of peripheral blood in patients with Brugada syndrome and healthy subjects. The main question it aims to answer is: Does DNA methylation changes distinguish Brugada patients from healthy controls? Does DNA methylation changes distinguish Brugada patients with high versus low risk of sudden cardiac death?
Detailed description
The Investigators will enroll 10 patients with Brugada syndrome and 10 age and sex matched healthy controls. We will collect 5 mL of peripheral blood and will analyze genome-wide DNA methylation via EPIC array platform. Bioinformatic algorithms and network analysis will be applied to identify possible diagnostic and predictive biomarkers.
Primary outcome measures
- Number of differentially methylated genes as assessed by EPIC microarray [Time frame: 3 months]
Secondary outcome measures (1)
- Diagnostic performance of differentially methylated regions predicting the risk of sudden cardiac death [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Brugada syndrome was confirmed when the 12-lead ECG showed ST-segment elevation with a type-1 morphology of ≥2 mm in ≥1 right precordial lead either spontaneously or after a provocative drug test (intravenous administration of a Class I antiarrhythmic) in the absence of any structural heart disease.
- >18 years
- Unrelated patients
Exclusion criteria
- Related patients
- Not type 1 Br patter
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Benincasa G, Pepin ME, Russo V, Cacciatore F, D'Alto M, Argiento P, Romeo E, Chiappetti R, Laezza N, Wende AR, Schiattarella GG, Coscioni E, La Montagna A, Amarelli C, Maiello C, Golino P, Condorelli G, Napoli C. High-resolution DNA methylation changes reveal biomarkers of heart failure with preserved ejection fraction versus reduced ejection fraction. Basic Res Cardiol. 2025 Apr;120(2):347-361. d PMID 39725721
Identifiers
NCT: NCT06888271 · Vanvitelli-Benincasa G · PE00000015